BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE

    MDR report key: 1790029 · Received August 2, 2010

    Report

    Report Number
    2210968-2010-00892
    Event Type
    Injury
    Date Received
    August 2, 2010
    Date of Event
    July 3, 2010
    Report Date
    July 5, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) (INFECTION): THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN REPLACED; HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A GALACTOPHORE RESECTION PROCEDURE ON (B)(6)2010 AND SUTURE WAS USED. ON (B)(6)2010, THE PATIENT'S WOUND APPEARED RED AND SWOLLEN AND THE SUTURE TURNED BLACK. THE SURGEON USED ANTIBIOTIC TO TREAT THE PATIENT. NOW THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA BH6941

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention